EXPERT CONSULTANT IN USABILITY ENGINEERING (IEC 62366) FOR MEDICAL DEVICES
Develop a safe, intuitive medical device compliant with IEC 62366 for CE marking and FDA clearance
At every stage of the usability engineering process, we help you secure your medical device, strengthen your MDR 2017/745 and IVDR 2017/746 files, and design interfaces built for real users.
Safe and effective devices, through usability engineering expertise
Leveraging our expertise in human factors, ergonomics and regulatory affairs, we help you design and evaluate medical devices that are safe, intuitive and compliant with safety standards.
Without a usability engineering approach,
you are taking risks
Late and costly changes
Discovering a use problem at the end of development means emergency changes to your device. The result: months of delay and a budget that explodes (up to 10 times more expensive than an anticipated change!*).
Product recalls due to use errors
Between 2010 and 2012, 36% of FDA medical device recalls were due to interface or design issues*. Errors that could have been avoided from the start of development.
Compromised adoption
A non-intuitive device that doesn't meet user needs will be rejected. Between loss of trust, dissatisfied customers and poor reputation, the impact can be severe.
Extended time to market
Non-compliance on the file, summative evaluation to redo, last-minute corrections… Without a clear method, certification becomes an obstacle course.
Complex and time-consuming standards
IEC 62366-1, TR 62366-2, ISO 11607, HF guidance… These standards accumulate and quickly become a headache for your teams already busy with development.
With Usarea, gain clarity and efficiency
Problems identified early
Our user studies quickly detect ergonomic issues and associated use errors, preventing costly changes at the end of the project.
Fewer product recalls
By anticipating use risks and integrating real user needs, we strengthen the safety of your devices.
Devices adopted more easily
An intuitive, user-centred interface drives adoption and satisfaction from day one on the market.
Faster compliance
We build a solid usability/human factors engineering file, meeting CE/FDA expectations, so you get your certifications faster.
Recognised expertise
With more than 10 years of combined experience, we master user research, design and usability standards to guide you at every step.
We support you throughout your project
Usability engineering
We support you through the complete usability engineering process for your medical device, ensuring compliance with CE and FDA requirements while enabling an intuitive and safe user experience.
- Formative evaluations, summative evaluation, risk analysis… to identify and prevent use errors.
- File compliant with IEC 62366 (MDR 2017/745 and IVDR 2017/746)
- Methodology aligned with your timelines and operational needs
Choose the personalised support that fits your needs
You have an internal team but want expert support at every stage?
You do it, we guide you.
You need a reliable partner to handle one or all stages of your project?
We take care of everything.
We handle certain key stages and support you on others.
A hybrid and flexible format.
We support all classes of medical devices (MD) & all types of health products
From Class I to Class III for MDR 2017/745, from A to D for IVDR 2017/746, as well as other health and innovation products, regulated or not. Whether it's a physical product, software, a medicine or accompanying documentation, we adapt our expertise to your needs.
Physical product
MD, implantable medical device
Application & software
Digital medical device (SaMD), digital interface
Medicine (MA)
Medicine, package insert & drug delivery device
In vitro diagnostic medical device
IVD
Accompanying document
Package insert, IFU, quick start guide, illustrations
Training material
Presentation, eLearning
They trust us
Amandine Broussier is a reliable, competent partner who guided us throughout our usability process. When we had questions about interpreting the standard and improving our products, Amandine gave us excellent advice. She is also a person of great human quality who knows how to build trust with testers and collaborators.
Discover our latest articles!
Design Validation vs. Human Factors Validation: what are the differences?
Read article
The Usability Engineering Report (UER): what is it, how to write it and what are the differences between CE marking and FDA clearance?
Read article
Package insert readability studies: a key step for Marketing Authorization (MA)
Read articleDo you prefer learning by video or podcast?
Our webinars & short formats
Learn more about usability engineering and IEC 62366, in under a minute or in depth.
Watch our videos
Our podcast
Listen to our experts and guests share their experience and practical advice for designing safe, intuitive and compliant medical devices.
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Your most frequently asked questions
A question or a project?
Write to us and we'll take the time to guide you and show you how to secure and improve your product.
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